“We understand and share the public’s interest in ensuring that every mother – whether insured or uninsured – who needs the medication will be able to access it in an affordable manner. That is why we recently announced a patient financial assistance program (PAP) that reduces the total out-of-pocket costs for qualified patients, and that eliminates out-of-pocket costs entirely for patients whose need is greatest.” — Makena “Commitment to Patient Access to Therapy”

“Continuing to compound this product after FDA approval of Makena renders the compounded product subject to FDA enforcement for violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance.” – threatening letter KV sent out to pharmacies that were making the compound as soon as they received their FDA approval